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Impact of Metabolic Syndrome on Rehabilitation Outcomes in Rotator Cuff Injury

NCT ID: NCT06946472

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-15

Study Completion Date

2026-03-05

Brief Summary

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This prospective comparative study aims to investigate the effect of Metabolic Syndrome (MetS) on the outcomes of a standardized rehabilitation program in patients with Rotator Cuff Injuries (RCI). Patients diagnosed with RCI will be divided into two groups based on the presence or absence of MetS, determined by NCEP-ATP III criteria. Both groups will receive the same 4-week physiotherapy protocol including hot pack, TENS, ultrasound, and therapeutic exercises. Pain intensity, pain threshold, muscle strength, kinesthesia, and shoulder functionality will be evaluated before and after treatment. The study hypothesizes that the presence of MetS negatively affects rehabilitation outcomes in patients with RCI by altering inflammation and tissue healing processes.

Detailed Description

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This study aims to investigate the differences in shoulder function and rotator cuff tear outcomes between individuals with and without Metabolic Syndrome (MetS). Participants will be divided into two groups: the MetS group, which meets at least three of the NCEP-ATP III criteria for Metabolic Syndrome, and the non-MetS group, which does not have MetS.

Both groups will undergo an initial assessment, focusing on shoulder function, rotator cuff tear status, and associated factors such as age, gender, and general health conditions. The study will explore how MetS may impact the recovery and function of the shoulder in individuals with rotator cuff tears, aiming to provide insights into potential treatment and rehabilitation strategies for this population.

Data will be collected at a single time point (cross-sectional study) to evaluate baseline conditions and differences between the two groups. Statistical analyses will be performed to compare outcomes and explore potential correlations with MetS criteria.

Conditions

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Rotator Cuff Injury (RCI) Metabolic Syndrome (MetS)

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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RCI with MetS

Participants with rotator cuff injury and diagnosed metabolic syndrome.

No interventions assigned to this group

RCI without MetS

Participants with rotator cuff injury but without metabolic syndrome.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Aged between 18-65 years
* Willing to participate in the study
* Unilateral Rotator Cuff Tear (RMY)

In addition to the above criteria, meeting at least three of the NCEP-ATP III consensus criteria for Metabolic Syndrome Stable metabolic syndrome (e.g., no significant medical changes in the last 3 months)

Exclusion Criteria

* Inability to cooperate with the tests or presence of mental health issues
* Presence of cervical radiculopathy symptoms
* Presence of other orthopedic pathologies in the same shoulder (e.g., fracture, prosthesis, avascular necrosis, advanced shoulder osteoarthritis, frozen shoulder, severe scapular dyskinesia, neurological diseases, etc.)
* Presence of function-limiting neurological, vascular, or cardiac issues
* Local steroid injection to the shoulder within the last 3 months
* Receipt of physiotherapy or rehabilitation within the last 3 months
* Systemic rheumatic or inflammatory diseases
* Surgical history due to chronic rotator cuff tear
* Diagnosis of glenohumeral joint or acromioclavicular joint arthritis
* Severe scapular dysfunction or significant postural abnormalities
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Elif Dilara Durmaz

OTHER

Sponsor Role lead

Responsible Party

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Elif Dilara Durmaz

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Name: Karamanoğlu Mehmetbey University Faculty of Medicine, Yunus Emre Mah. Dr. Aziz Tarhan Cad. No:21 City: Karaman Postal Code: 70200 Country: Turkey

Karaman, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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MetS-2025-001

Identifier Type: -

Identifier Source: org_study_id